NCT04928430终止2 期
An International, Placebo-controlled, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of 150 mg XAV-19 Infusion, in Patients With Moderate to Severe COVID-19: the EUROXAV Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 290
- 试验地点
- 18
- 主要终点
- Proportion of patients with an aggravation of COVID-19
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of XAV-19 drug in patients with moderate-to-severe COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I1) Male or female patient aged 18 years or over, weighing >50 Kg and <120 Kg, at the time of signing the informed consent,
- •I2) Patient presenting in a specialized or an emergency unit
- •I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea
- •I4) Patient with SpO2 > 90% (at ambient air)
- •I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening
- •I6) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and use a highly effective birth control until 90 days after the administration of study drug
- •I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug,
- •I8) Patient capable of giving signed informed consent.
排除标准
- •E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit
- •E2) Patient with multiorgan failure
- •E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization
- •E4) Patient participating in another clinical trial with an investigative agent
- •E5) Pregnancy or breastfeeding
研究组 & 干预措施
XAV-19
Experimental
XAV-19
干预措施: XAV-19 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with an aggravation of COVID-19
时间窗: within 8 days after treatment
The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO 7-point ordinal scale at randomization.
次要结局
- Change in Clinical parameters : body temperature(Between randomization and Day 3, 5, 8 and 15)
- Change in Clinical parameters : Respiratory rate(Between randomization and Day 3, 5, 8 and 15)
- Change in Clinical parameters : SpO2 at ambiant air(Between randomization and Day 3, 5, 8 and 15)
- Change in Clinical parameters : Supplemental O2(Between randomization and Day 3, 5, 8 and 15)
- Change in severity on Common Terminology Criteria of Adverse Events (CTCAE) scale (version 5.0)(Between randomization and Day 3, 5, 8 and 15)
- Duration of patient's requirement in supplemental O2(up to 15 days)
- Duration of aggravation(up to 15 days)
- Length of hospital stay(up to 15 days)
- Viral status: RT-PCR or RT-qPCR for SARS-CoV-2(At randomization and on Day 8 or at the end of follow-up, whichever comes first)
- Proportion of patients referred to Intensive Care Unit (ICU)(Between randomization and Day 3, 5, 8 and 15)
- Proportion of patients with need for mechanical ventilation(At randomization and at Day 3, 5, 8 and 15)
- Survival rates(at day 8 and day 15 after randomization)
- Safety: Occurrence of adverse effects(up to 15 days)
- Safety: hypersensitivity or allergy(up to 15 days)
- Safety: laboratories abnormalities : white blood cell count(up to 15 days)
- Safety: laboratories abnormalities : red blood cell count(up to 15 days)
- Safety: laboratories abnormalities : hemoglobin(up to 15 days)
- Safety: laboratories abnormalities : platelets(up to 15 days)
- Safety: laboratories abnormalities : creatinine(up to 15 days)
研究者
研究点 (18)
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